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| Name | Class |
|---|---|
| Manchester University NHS Foundation Trust | OTHER_GOV |
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The study will examine the effect of amino acid supplements and enhanced physiotherapy on physical recovery following critical illness in intensive care.
Critically ill patients aged 45 years and over will be recruited during recovery after intensive care. Using a randomised controlled, blind at follow-up design the study will examine whether the combination of an amino acid supplement and an enhanced physiotherapy programme improve the rehabilitation of muscle following intensive care better than a self-guided rehabilitation programme alone or with either an amino acid supplement or the enhanced physiotherapy programme. The Primary efficacy outcome will be the improvement in six minute walking test measured at 3 months post intensive care discharge. Secondary efficacy parameters will be insulin resistance, health related quality of life and muscle mass using DEXA scanning at 3 months and 1 year post intensive care discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICU Recovery Manual & placebo supplement | Active Comparator | Patients will receive the standard self-directed rehabilitation package and a placebo nutritional supplement |
|
| ICU recovery manual & amino acid (AA) supplement | Experimental | Patients will receive the standard self-directed rehabilitation package with the essential amino acid supplement |
|
| PEPSE & placebo supplement | Experimental | Patients will receive the standard self-directed rehabilitation package plus PEPSE and the placebo nutritional supplement |
|
| PEPSE & AA supplement | Experimental | Patients will receive the standard self-directed rehabilitation package plus PEPSE and the essential amino acid nutritional supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amino acid supplement | Dietary Supplement | Flavoured essential amino acid supplement and glutamine dipeptide taken twice daily for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in the distance walked by patients in 6 minutes (6 minute walk test) between recruitment to the study and 3 months post intensive care discharge | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in insulin resistance between recruitment to the study and the 1 year follow-up point | 1 year | |
| Improvement in patients perception of their health related quality of life between recruitment to the study and the 1 year follow-up point | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard D Griffiths, MD | St Helens & Knowley Teaching NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Helens & Knowsley Teaching NHS Trust | Prescot | Merseyside | L35 5DR | United Kingdom | ||
| Central Manchester University Hospitals NHS Foundation Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26004031 | Derived | Jones C, Eddleston J, McCairn A, Dowling S, McWilliams D, Coughlan E, Griffiths RD. Improving rehabilitation after critical illness through outpatient physiotherapy classes and essential amino acid supplement: A randomized controlled trial. J Crit Care. 2015 Oct;30(5):901-7. doi: 10.1016/j.jcrc.2015.05.002. Epub 2015 May 9. |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007362 | Intensive Care Units |
| ID | Term |
|---|---|
| D006757 | Hospital Units |
| D006268 | Health Facilities |
| D005159 | Health Care Facilities Workforce and Services |
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| PEPSE | Other | Enhanced physiotherapy programme of 3 1 hour sessions per week for 6 weeks while in hospital and once discharged home 1 supervised outpatient session of 1 hour and 2 home exercise sessions per week (PEPSE). |
|
| Intensive Care Unit (ICU) Recovery Manual | Other | Standard self-directed 6 week rehabilitation package |
|
| Placebo nutritional supplement | Dietary Supplement | Cherry flavoured low calorie and low protein placebo drink |
|
| Increase in muscle mass and bone density assessed using dual energy x-ray absorptiometry (DEXA) scanning between recruitment to the study and the 1 year follow-up point | 1 year |
| Manchester |
| M13 9WL |
| United Kingdom |